Multiple Sclerosis Clinical Trial
Official title:
Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis
Verified date | November 2018 |
Source | State University of New York at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to apply baseline MRI and neuropsychological measures to predict patient
responses to behavioral cognitive rehabilitation. Training will take place over 12 weeks, 1
hour per day, 5 days per week.
The investigator hypothesizes the following:
[1a] The investigator expects that individuals with low baseline Conscientiousness will
experience a lower magnitude of overall cognitive improvement following rehabilitation
1. b] The investigator expects the impact of Conscientiousness on fidelity of
rehabilitation will in part be moderated by individual differences in program adherence
and executive function
2. a] The investigator expects that individual differences in structural and functional
connectome disturbances will in part explain differences in participant responses to
cognitive rehabilitation.
This study will also serve to supplement the sample of participants for the current IRB
approved study ((IRB: 603069, Title: A case-control, 5-year follow-up study of
cardiovascular, environmental and genetic risk factors for disease progression in patients
with multiple sclerosis.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 20, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: For all subjects: - males and females above age 18 - fluent in English - education >9 years Additional inclusion criteria for MS patients are as follows: - Clinically definite MS diagnosis - Expanded Disability Status Scale (EDSS) = 6.5 - MS patients must be relapse-free and stable from the time of their MRI acquired for the CEG-MS study - Willing and able to comply with the study procedures for the duration of the trial Exclusion Criteria: - history of serious medical or psychiatric illness (other than MS in the patient group) that may affect cognitive functioning - color-blindness - history of developmental disability - past or current alcohol or substance dependence - History of major depressive disorder, bipolar disorder, or psychotic disorder predating the onset of MS - History of traumatic brain injury as defined by trauma causing loss of consciousness or transient post-traumatic or retrograde amnesia exceeding 5 min - Other pathology related to MRI abnormalities |
Country | Name | City | State |
---|---|---|---|
United States | Jacobs Comprehensive Multiple Sclerosis Treatment and Research Center | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of Conscientiousness on Cognitive Training Outcomes | The investigator expects baseline Conscientiousness to correlate positively with cognitive gains following rehabilitation. Conscientiousness will be measured using the NEO-Five Factor Inventory (NEOFFI). All scores for personality testing will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units. |
This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation) | |
Primary | Cognitive Training Outcomes | Cognitive gains will be measured according to differences between baseline and followup testing for the following tests of cognition. Brief Visuospatial Memory Test (BVMT). This is a test of visual and spatial learning and memory. California Verbal Learning Test (CVLT). This is a test of verbal learning and memory. Symbol Digit Modalities Test (SDMT). This is a test of visual information processing speed. All scores for cognitive testing will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units. |
This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation) | |
Secondary | Moderating role of executive function | The investigator will assess whether baseline scores of executive function moderate the impact of Conscientiousness on cognitive training. Executive function will be reported according to scores on the following tests. Delis-Kaplan Executive Function System (D-KEFS) Tower Test. D-KEFS Sorting Test. Elithorn Perceptual Maze Test (EPMT). All scores for executive function will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units. |
12 weeks, as above | |
Secondary | Moderating role of program adherence | The investigator will assess whether daily program adherence is a moderates the impact of Conscientiousness on cognitive training. Daily program adherence will be measured according to days and hours spent on cognitive training exercises. | 12 weeks, as above | |
Secondary | Impact of baseline brain connectivity on cognitive rehabilitation outcomes | The investigator will assess whether individual differences in structural and functional connectome disturbances in part explain differences in participant responses to cognitive rehabilitation. In order to address outcome number 5, white matter tract disruption will be characterized in order to determine how structural networks are impacted by white matter lesions. Tract disruption will be reported as the proportion of tracts normally connecting pairs of gray matter brain regions which are disrupted by lesions. These will therefore be reported as percent values. |
12 weeks, as above |
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